Train staff to comply with the requirements of Good Distribution Practice

​

This standard is to train staff to comply with the requirements of Good Distribution Practice (GDP).

It covers initial and continuing training for all staff, relevant to their role, in accordance with a written training programme. The training should include aspects of product identification, the avoidance of falsified medicines entering the supply chain, and include specific training for hazardous products, radioactive materials, products presenting special risks of abuse (including narcotic and psychotropic substances), and temperature-sensitive products.

The Responsible Person (RP) should also maintain their competence in Good Distribution Practice (GDP) through regular training.

This standard is for the nominated Responsible Person (RP) and all relevant staff engaged in the distribution of medicinal products.

---

1. ​confirm that the written training programme in place for all staff engaged in the distribution of medicinal products, covers compliance with the relevant legislative framework and regulations in relation to Good Distribution Practice (GDP)
2. confirm that training includes the identification of falsified medicinal products and how to avoid them entering the supply chain
3. develop and maintain a system for identifying and recording all staff individual training needs on Goods Distribution Practice
4. confirm records of training are maintained in accordance with the relevant codes of practice, organisational and regulatory requirements
5. evaluate and document the effectiveness of training, taking corrective and preventative action, where required
6. confirm that training is continually updated to maintain product integrity and compliance with the relevant legal, regulatory and organisational requirements

---

1. the relevant legislative framework and regulations in relation to Good

2. Distribution Practice (GDP)

3. the roles and authority of the relevant regulatory bodies
4. the consequences of non-compliance with the relevant regulations
5. the relevant regulatory and training requirements of the Responsible Person (RP) to comply with Good Distribution Practice (GDP)
6. the relevant legislative, regulatory and organisational requirements in relation to the required training for staff engaged in the distribution of medicinal products
7. what should be contained in a training programme for staff engaged in the distribution of medicinal products, to comply with the requirements of Good Distribution Practice (GDP)
8. the importance of including current and emerging product identification methods and techniques, and the identification of falsified medicinal products, in the training
9. when specific training is required for staff engaged in the distribution of medicinal products
10. how to undertake a training needs analysis
11. how to develop and maintain training records to confirm that staff engaged in the distribution of medicinal products have been trained to comply with the requirements of Good Distribution Practice (GDP)
12. how to maintain communication with those involved in the training process
13. how to evaluate and document whether the training that staff receive complies with the requirements of Good Distribution Practice (GDP)
14. the importance of continuing training for staff engaged in the distribution of medicinal products, to ensure they continue to comply with the requirements of Good Distribution Practice (GDP)

---

---

---

---

---

---

---

Good Distribution Practice (GDP):

the part of quality assurance that ensures that the quality of medicinal products is maintained through all stages of the supply chain. This refers to the procurement, holding, storage or distribution of medicinal products to retailers, pharmacies, wholesale dealers or the person authorised to supply medicinal products, who must be in possession of the relevant authorisation issued by the Secretary of State. The distribution of medicinal products includes both those for human and veterinary use and must comply with the rules and guidelines on Good Distribution Practice.

* *

Falsified medicinal products:

a term covered by legislation which refers to products that pose a major threat to public health. The term is used to distinguish the issue from Intellectual Property (IP) violations – which are generally referred to as "counterfeit" products – and can include poor quality or the wrong ingredients or materials, and incorrect dosage.

Responsible Person:

the nominated person who is held accountable for delivering the requirements

of GDP as defined in European Guidelines 2013/C 68/01 and:

• should be continuously contactable
• should fulfil responsibilities personally
• can delegate duties but not responsibilities

* *

specific training is required for hazardous products, radioactive materials, products presenting special risks of abuse (including narcotic and psychotropic substances), and temperature-sensitive products.

---

---

---

3

---

2027

---

Current

---

Original

---

Lantra

---

SFLGDP2

---

Goods Handling and Storage occupations, Managers and Senior Officials, Managers in Distribution, Storage and Retailing, Retailing and Wholesaling, Warehouse and Distribution

---

1243

---

develop; maintain, good distribution practice, compliance

---